EUCTR2012-000452-34-NL进行中（未招募）1 期
Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria - PRIORITY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Written informed consent must be provided before participation.
- •Patient information and consent form must be approved by relevant
- •independent EC. Specifically, all participating patients will be asked to
- •give informed consent for long-term follow-up and collection of followup
- •Male or female patients = 18 years and < 75 years of age at Screening
- •Type 2 DM (WHO criteria)
- •Persistent normoalbuminuria (at least 2 of 3 UACR < 30 mg/g samples
- •from run in period)
- •eGFR > 45 ml/min/1.73m2 at Screening visit
- •The patient must be willing and able to comply with the protocol for
- •the duration of the study
- •Female without child-bearing potential at the screening visit. Defined
- •as one or more of following:
- •- Female patients = 50 years of age at the day of inclusion, who have
- •been postmenopausal for at least 1 year
- •- Female patients < 50 years of age at the day of inclusion, who have
- •been postmenopausal for at least 1 year and serum FSH levels > 40
- •mIU/mL as well as serum estrogen levels < 30 pg/ml or a negative
- •estrogen test
- •- 6 weeks after surgical sterilization by bilateral tubal ligation or
- •bilateral ovariectomy with or without hysterectomy
- •OR a negative urine pregnancy test at the Screening visit AND one or
- •more of the following:
- •- Correct use of reliable contraception methods. This includes one or
- •more ofthe following: hormonal contraceptive (such as injection,
- •transdermal patch, implant, cervical ring or oral) or an intrauterine
- •device (IUD) OR correct use of double barrier with one of the following:
- •barrier methods (diaphragm, cervical cap, Lea contraceptive, femidom or
- •condom) AND in combination with a spermicide
- •- General sexual abstinence from the time of screening, during the study
- •until a minimum of 30 days after the last administration of study
- •medication if this is already established as the patient's preferred and
- •usual lifestyle.
- •- Having only female sexual partners
- •- Sexual relationship with sterile male partners only
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 660
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1340
排除标准
- •Average of systolic BP < 110 or > 160 mm Hg at baseline
- •Average of diastolic BP > 100 mm Hg at baseline
- •Type 1 DM (WHO criteria)
- •HbA1c <6.5% (48 mmo l/ mol) AND > 5 years of known duration of diabetes type 2 AND never treated with a antidiabetic drug of any kind.
- •Current in treatment with more than one RAAS blocking agent (Angiotensin Converting Enzyme inhibitor, Angiotensin Receptor Blocker or Direct Renin Inhibitor)
- •Current lithium treatment (ATC: N05AN)
- •Known or suspected hypersensitivity to Spironolactone or to any of its excipients
- •Current use of potassium sparing diuretics (ATC: C03D, C03E), such as: Spironolactone, Eplerenone or amiloride etc
- •Hyperkalemia at Screening: plasma potassium level >5.0 mmol/L or serum potassium level >5.4 mmol/L.
- •Hyponatriemia determine by the investigator
- •Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)
- •Any clinically significant disorder, except for conditions as-sociated with type 2 DM history, which in the Investigators opinion could interfere with the results of the trial
- •Cardiac disease defined as: Heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or MI, stroke, PTCA or CABG within the last 3 months
- •Diagnosis of non-Diabetic CKD current or in the past
- •Diagnosis of liver cirrhosis with current impaired liver function within the last 3 years.
- •Diagnosis of Addison's disease
- •Being lactating
- •Intend to become pregnant within the duration of the study or not use adequate birth control.
- •Known or suspected abuse of alcohol or narcotics
- •Not able to understand informed consent form
- •Participation in any other intervention trial than PRIORITY or a related sub-study is not allowed within 30 days before inclusion or concurrent to this study
研究者
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